Lipocine

Lipocine, Inc. is a clinical-stage biopharmaceutical company, which engages in the research and development of the delivery of drugs using proprietary delivery technology. The firm is involved in applying oral drug delivery technology for the development of pharmaceutical products focusing on metabolic and endocrine disorders. It offers TLANDO, an oral testosterone replacement therapy. The company was founded in 2011 and is headquartered in Salt Lake City, UT.

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Lipocine, Inc. is a clinical-stage biopharmaceutical company, which engages in the research and development of the delivery of drugs using proprietary delivery technology. It offers TLANDO, an oral testosterone replacement therapy. The company was founded on October 13, 2011 and is headquartered in Salt Lake City, UT.

SALT LAKE CITY , Dec. 17, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis. LPCN 1148, an oral prodrug of bioidentical testosterone, was recently studied in a proof-of-concept (POC) Phase 2 study in patients with decompensated cirrhosis.

FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis

SALT LAKE CITY , Nov. 18, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced the publication and discussion of a manuscript "Oral LPCN 1148 Improves Sarcopenia and Hepatic Encephalopathy in Male Patients with Cirrhosis: a randomized, placebo-controlled Phase 2 trial" in the journal Hepatology and discussion at The Liver Meeting (AASLD) 2024 Editor's Cut: Clinical Study Session held on November 16, 2024. LPCN 1148 is targeted to be a "First in Class" product candidate with a novel mechanism of action for overt hepatic encephalopathy and sarcopenia indications.

Lipocine Announces Publication and Discussion of LPCN 1148 Manuscript at The Liver Meeting 2024 Editor's Cut Session

SALT LAKE CITY , Nov. 7, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the third quarter and nine months ended September 30, 2024 and provided a corporate update. Neuroactive Steroids LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depression (PPD).

Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2024

SALT LAKE CITY , Oct. 31, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced a license, development and supply agreement with to SPC Korea http://spcpharm.co.kr granting exclusive rights to market TLANDO® in South Korea. Under the terms of the distribution and license agreement, Lipocine will receive an upfront payment and is also eligible to receive certain regulatory and sales milestone payments, including a payment upon regulatory approval of TLANDO in South Korea.

Lipocine Announces Distribution and License Agreement with SPC Korea to Commercialize TLANDO® in South Korea

Quantitative Electroencephalogram (qEEG) in healthy subjects administered single doses of oral brexanolone, a neuroactive steroid (NAS), confirmed GABAA modulation Rapid and durable CNS target engagement confirms effective oral delivery of bioidentical brexanolone Promising results support continued development of oral brexanolone for the treatment of neuropsychiatric disorders SALT LAKE CITY , Oct. 10, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced positive data from its qEEG study of its oral brexanolone, a proprietary bioidentical NAS being developed for the treatment of post-partum depression (PPD). Changes in spectral power (a quantitative measure of the strength or intensity of specific brain wave frequencies) are frequently used to characterize the effects of drug candidates and may have utility in indication and dose selection in CNS clinical trials.

Lipocine Announces Positive Oral Brexanolone Quantitative EEG Results

SALT LAKE CITY , Oct. 8, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced an exclusive supply and distribution agreement with Pharmalink https://pharmalink.ae/ to commercialize TLANDO®, its oral testosterone replacement therapy, in the Gulf Cooperation Council (GCC) countries consisting of Saudi Arabia, Kuwait, the United Arab Emirates (UAE), Qatar, Bahrain, and Oman.  Under the terms of the agreement, Lipocine received an upfront payment from Pharmalink and, upon Marketing Authorizations (MA) in individual GCC countries, Lipocine will provide TLANDO drug product to Pharmalink at an agreed transfer price.

Lipocine Announces Supply and Distribution Agreement with Pharmalink to Commercialize TLANDO® in the Gulf Cooperation Council (GCC) Countries

SALT LAKE CITY , Oct. 2, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that it will host a virtual key opinion leader (KOL) event on LPCN 2401 for improved body composition in obesity management on Wednesday, October 16, 2024 at 11:00 am ET. To register, click here.

Lipocine to Host Virtual KOL Event on LPCN 2401 for Improved Body Composition in Obesity Management on October 16, 2024

SALT LAKE CITY , Sept. 30, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that it will present and meet with investors at the H.C.

Lipocine to Present at H.C. Wainwright 8th Annual MASH Investor Conference

Study evaluated LPCN 2401 in participants with obesity (BMI ≥30) and participants with BMI ≥27 with at least one weight-related comorbidity SALT LAKE CITY , Sept. 5, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that a poster featuring Phase 2 data on LPCN 2401 will be presented at the Obesity Society's Annual ObesityWeek® conference to be held November 3 – 6, 2024 in San Antonio, TX.

Lipocine Announces Phase 2 Data on LPCN 2401 to be Presented at ObesityWeek®

SALT LAKE CITY , Aug. 27, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that Dr. Mahesh V. Patel, President and Chief Executive Officer, will present and meet with investors at the H.C.

Lipocine to Present at H.C. Wainwright 26th Annual Global Investment Conference

SALT LAKE CITY , Aug. 8, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the second quarter ended June 30, 2024 and provided a corporate update. LPCN 1154 for Postpartum Depression (PPD) In June 2024, Lipocine announced positive topline study results from the NDA enabling study of LPCN 1154.

Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2024

Met standard bioequivalence (BE) criteria Cmax, AUC0-t, and AUC 0- ∞ Ctrough criterion was met LPCN 1154 was well tolerated with no sedation or somnolence events observed On track for NDA filing, targeted by end of Q4 2024 SALT LAKE CITY , June 25, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced positive topline study results demonstrating bioequivalence of LPCN 1154 to IV brexanolone in an NDA enabling pivotal pharmacokinetic (PK) study.  Lipocine is developing LPCN 1154, oral brexanolone, for the treatment of postpartum depression (PPD).

Lipocine Announces LPCN 1154 Meets Bioequivalence with IV Brexanolone in Pivotal Study

SALT LAKE CITY , June 10, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced that Phase 2 results on LPCN 1148 in cirrhosis were featured in a late breaking oral presentation at the European Association for the Study of Liver (EASL) Congress on Saturday, June 8, in Milan, Italy. The presentation "Intervention with oral LPCN 1148 improves sarcopenia and hepatic encephalopathy (HE) in patients with cirrhosis: a 52-week phase 2 randomized clinical trial" was presented by Arun J.

Lipocine Presents 52 Week Results from LPCN 1148 Phase 2 Study in Late Breaking Session at EASL Congress 2024

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SALT LAKE CITY , May 9, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2024 and provided a corporate update. LPCN 1154 for Postpartum Depression In May 2024, dosing of subjects was completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154.

Lipocine Announces Financial Results for the First Quarter Ended March 31, 2024

SALT LAKE CITY , May 8, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced that data from the Phase 2 study of LPCN 1148 has been selected for a late breaking oral presentation at the European Association for the Study of Liver ("EASL") Congress, to take place June 5 to 8, 2024 in Milan, Italy. Presentation Details Title    Intervention with oral LPCN 1148 improves sarcopenia and hepatic encephalopathy ("HE") in patients with cirrhosis: a 52-week phase 2 randomized clinical trial Presenter:   Dr. Arun J.

Lipocine Announces Late Breaking Oral Presentation of Data from the Phase 2 Study of LPCN 1148 at EASL Congress 2024

Pivotal study design aligned with FDA on streamlined pathway to NDA submission goal in 2024 Topline results anticipated late in 2Q 2024 SALT LAKE CITY , May 1, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced that dosing of subjects has been completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed as a treatment of postpartum depression (PPD).

Lipocine Announces Completion of Dosing in Pivotal Study of Postpartum Depression Candidate, LPCN 1154

LPCN 2401 treatment resulted in statistically significant body composition improvement in men Increased lean mass (LM) by 4.4% and decreased fat mass (FM) by 6.7% Reduced android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8% Well-tolerated, adverse events (AEs) similar to placebo Potential for use in combination with incretin mimetics (GLP-1/GIP agonists and/or post GLP-1/GIP agonist) or as a monotherapy post discontinuation Conference call and webcast at 8.30 a.m. ET today SALT LAKE CITY , April 11, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced results from a Phase 2 clinical trial (NCT04134091) which includes LPCN 2401, an oral proprietary combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant.

Lipocine Announces Positive LPCN 2401 Clinical Results Showing Improved Body Composition in Participants with Obesity

Met primary and Hepatic Encephalopathy (HE) endpoints in Phase 2 study Increase in Skeletal Muscle Index (SMI) observed at Week 24 was maintained through 52 weeks Participants on placebo increased SMI when switched to LPCN 1148 Fewer Overt Hepatic Encephalopathy (OHE) events and time to first recurrent OHE event was longer while on LPCN 1148 therapy LPCN 1148 was well-tolerated, with AE rates and severities similar to placebo. Participants on LPCN 1148 were hospitalized for fewer days SALT LAKE CITY , March 28, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company today announced positive topline results from a Phase 2 clinical study of LPCN 1148.

Lipocine Announces Positive Week 52 Results from LPCN 1148 Phase 2 Study in Patients with Cirrhosis

Company anticipates topline results from this crossover pivotal study late in the second quarter of 2024 SALT LAKE CITY , March 25, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that study enrollment is complete and the first cohort of subjects has been dosed in pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed by Lipocine for the treatment of postpartum depression (PPD).

Lipocine Announces First Cohort Dosed in Pivotal Study of LPCN 1154

SALT LAKE CITY , March 7, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders, today announced financial results for the year ended December 31, 2023 and provided a corporate update. Neuroactive Steroids Lipocine announced positive topline results from a pharmacokinetics ("PK") pilot bridge study of LPCN 1154 (oral brexanolone).

Lipocine Announces Financial Results for the Full Year Ended December 31, 2023

SALT LAKE CITY , March 6, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that Dr. Mahesh V. Patel, President and Chief Executive Officer, will participate in a fireside chat and meet with investors at the 36th Annual Roth Conference, to take place in Laguna Niguel, CA, on March 18.

Lipocine to Present at 36th Annual Roth Conference

Positive clinical study results confirm 48-hour dosing regimen for the pivotal PK study On track for Q2-24 pivotal study topline results and planned Q4-24 NDA filing  SALT LAKE CITY , Feb. 6, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that results from a multi-dose clinical study have confirmed the LPCN 1154 48-hour dosing regimen for the upcoming NDA enabling pivotal pharmacokinetic (PK) study. LPCN 1154 is an oral neurosteroid being developed by Lipocine for the treatment of postpartum depression (PPD).

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